OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM

OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K071015) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 2007. Regulation: 8.